FUTURE OF ANTIBODY PURIFICATION

Monoclonal antibodies (mAbs) have contributed to significant advances in the treatment of multiple diseases, including cancer. Primary recovery is the interface between the upstream and downstream components of the mAb production process. Most mAb processes today are based on the large-scale use of Protein A. Continuous processing in biopharmaceutical manufacturing involves an uninterrupted flow of material through each unit operation, from upstream cell culture to downstream purification. Advances in the mechanistic understanding of viral clearance and inactivation have been achieved through the analysis of United States Food and Drug Administration databases and large industrial datasets. Significant capital investment has been the hallmark of current and emerging antibody manufacturing facilities. Disposable technology is an integral tool that is especially relevant for the production of clinical candidates. Process analytical technology implementation now spans raw material testing, final product real-time release testing, and broader quality control efforts.